Assessment of Whether Telehealth Family Psychoeducation for Major Depressive Disorder is Doable

Condition(s) studied

Investigational drug(s) / intervention(s)

Family psychoeducation: The study intervention, tagged SPARKED (Supportive Program for Advancing Recovery, Knowledge, and Empowerment in Depression), is a co-designed family-based psychoeducational intervention for individuals with MDD and their family members or caregivers. The intervention will cover structured modules to enhance participants' understanding of MDD and its treatment, coping strategies, and self-efficacy skills. It will also focus on recognising early signs of relapse and empowering participants to engage actively in treatment decision-making.

Study summary

The goal of this single-arm interventional study is to assess the feasibility and acceptability of co-designed telehealth family psychoeducation (FPE) among individuals with major depressive disorder (MDD) and families. The study will also assess the intervention's preliminary impact on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. The main questions it aims to answer are:

* What are patients', families', and mental health professionals' views about telehealth FPE for MDD?
* What are the feasibility and acceptability of telehealth FPE for MDD among individuals with MDD and their families?
* What is the preliminary impact of telehealth FPE for MDD on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns?

Study participants will include individuals with MDD who have prescriptions for antidepressant medications and their family members. Participants will receive three biweekly FPE sessions and a six-week follow-up session via telehealth using a single-family format. The study intervention, telehealth family psychoeducation for MDD, will cover structured modules to enhance participants' understanding of MDD and its treatment, coping strategies, and self-efficacy skills. It will also focus on recognising early signs of relapse and empowering participants to engage in treatment decision-making actively. Hence, the study intervention is termed the Supportive Program for Advancing Recovery, Knowledge, and Empowerment in Depression (SPARKED).

At baseline, post-intervention, and follow-up, participants with MDD will complete self-reported measures for personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. In contrast, their family members or caregivers will complete only an outcome measure for medication necessity beliefs and concerns.

Eligibility

Primary outcome measure(s)

• Recruitment rate — Three months beginning on the date the feasibility study flyer is displayed.
  The total number of eligible participant dyads (an individual with MDD and a supportive family member) enrolled on the feasibility study within the recruitment period.
• Retention — Across the entire trial period, from enrolment to six-week follow-up.
  The percentage of participants who remain in the study.
• Outcome measure return rate — From enrolment to the end of six-week follow-up.
  The percentage of participants who return filled-out self-report measures.
• Outcome measure completion rate — From enrolment to the end of the six-week follow-up.
  The percentage of participants who successfully complete a specific outcome measurement.
• Prospective acceptability — During the recruitment period, lasting approximately three months.
  Number of eligible participants who consented to study participation
• Concurrent acceptability — From the first biweekly session to the end of the six-week follow-up
  Number of family psychoeducational sessions attended and reasons for dropout
• Retrospective acceptability. — At six-week follow-up.
  Feedback on telehealth family psychoeducation for MDD, including what worked well, barriers encountered, and suggestions for improvement.

Trial sites (2)

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